[Edaily Reporter NA EUN-KYUNG ] It has been revealed that DuChemBio Co.,LTD.(176750)accounted for 96.3% of the domestic production value of radiopharmaceuticals used to diagnose Alzheimer’s disease last year. As domestic prescriptions for the Alzheimer’s treatment “Leqembi” (active ingredient: lecanemab) gained momentum, the production value and sales of related diagnostic agents also increased.

DuChemBio Co, LTD announced on the 22nd that, based on an analysis of the Ministry of Food and Drug Safety’s 2025 production performance by product, the combined production value of “Bizamil” and “NeuraCheck,” which it supplies, totaled 11.81 billion won. This figure accounts for 96.3% of the total production value of radiopharmaceuticals for diagnosing Alzheimer’s disease in South Korea and represents the highest level in the past three years.

The production value of radiopharmaceuticals for diagnosing Alzheimer’s dementia in Korea is also on the rise. According to production data from the Ministry of Food and Drug Safety’s “Medicine Safety Korea” portal, the figure increased from 7.2 billion won in 2023 to 8.03 billion won in 2024 and reached 12.27 billion won last year. The growth rate last year was 52.9%.

During the same period, the combined production value growth rate for Vizamil and Neuracheck rose from 12% in 2024 to 55% last year. This coincides with the time when prescriptions for Alzheimer’s disease treatments began in earnest in South Korea.

Leqembi received approval from the Ministry of Food and Drug Safety in May 2024 and was launched in South Korea in December of the same year. It is indicated for patients with mild cognitive impairment or mild Alzheimer’s disease caused by Alzheimer’s disease with confirmed amyloid pathology. Before starting treatment, beta-amyloid pathology must be confirmed through amyloid positron emission tomography (PET) or cerebrospinal fluid (CSF) testing.

Consequently, the expanding prescribing of anti-amyloid therapies is driving demand for diagnostic radiopharmaceuticals. In South Korea, amyloid PET radiopharmaceuticals used for diagnosing Alzheimer’s disease include Vizamil and Neuracheck—produced and supplied by DuChemBio Co, LTD—as well as “Alzaview” from FutureChem Co., Ltd.(220100).

The increase in production value has also translated into actual product sales this year. According to DuChemBio Co, LTD’s 2026 interim report, sales of Vizamil and Neuracheck in the first half of this year totaled 4.55 billion won, a 38.3% increase from the 3.29 billion won recorded in the same period last year. Compared to last year’s annual sales of approximately 7.5 billion won for these two products, the first half of this year accounted for about 61% of last year’s total annual sales.

The company believes that the increase in testing demand could also impact profitability. Radiopharmaceuticals are a business with significant fixed costs, including cyclotrons (particle accelerators), Good Manufacturing Practice (GMP) facilities, and specialized personnel. Since a single synthesis produces enough for multiple patients, the company explains that as the utilization rate of manufacturing facilities increases, the fixed cost per unit can decrease.

DuChemBio Co, LTD’s consolidated operating profit last year was 7.4 billion won, an increase of approximately 47% from the previous year. The operating profit margin also rose by about 5 percentage points, from approximately 14% in 2024 to approximately 19% last year.

Kim Sang-woo, CEO of DuChemBio Co, LTD, stated, “The radiopharmaceutical business has a high proportion of fixed costs—such as cyclotrons, GMP manufacturing facilities, and specialized radiation personnel—and operates on a structure where a single synthesis produces enough dosage to treat multiple patients.” He added, “As demand for tests increases and manufacturing facility utilization rates rise, the cost per unit decreases, which can lead to an operating leverage effect where revenue growth translates into profit growth.”

Another variable for the future is whether additional Alzheimer’s disease treatments will be introduced. Eli Lilly’s Alzheimer’s disease treatment “Kisunla” (active ingredient: donanemab) is currently undergoing marketing authorization review in South Korea. Kisunla also requires confirmation of beta-amyloid pathology prior to administration.

In particular, Kisunra was developed to allow clinicians to assess the degree of amyloid plaque reduction during treatment and determine whether to discontinue the medication. The company explains that if introduced in Korea, it could potentially impact not only patient selection for treatment but also the demand for amyloid PET scans during the course of treatment.

Unlike general pharmaceuticals, the production and supply chain are critical for radiopharmaceuticals. Fluorine-18 (F-18), used in Vizamil and Neuracheck, has a half-life of only about 110 minutes—the time it takes for its radioactivity to decrease by half—so it cannot be stored for long periods and must be supplied to medical institutions on the same day it is produced. DuChemBio Co, LTD currently operates 12 manufacturing facilities nationwide, five of which are GMP-certified. The company plans to expand its production and supply infrastructure to meet the growing demand for Alzheimer’s diagnosis.

DuChemBio Co, LTD is also working to expand access to testing. In May, DuChemBio Co, LTD signed a Memorandum of Understanding (MOU) with the Korean Neurological Society and is pursuing a plan to utilize hospitals certified by the Society as regional testing hubs. Since amyloid PET scans can only be performed at medical institutions equipped with the necessary equipment, the company plans to establish a system to refer patients treated at primary care facilities to PET scanning centers.

CEO Kim stated, “As Alzheimer’s disease treatment gains momentum, the importance of diagnostic infrastructure for accurately identifying eligible patients and monitoring treatment progress will grow.” He added, “With the introduction of new Alzheimer’s disease treatments following Lecembi, the number of patients requiring testing and the frequency of testing are likely to increase. Therefore, we will strengthen our stable supply system and focus our 2027 investments on expanding manufacturing facilities and diagnostic infrastructure.”